95,114 total recalls in our database
Flowonix Medical
A pump alarm function anomaly in the pump firmware code may result in the pump not sending the expected error code notifications to the Programmer, or not emit an audible alarm tone in certain "out of tolerance" conditions associated with the pump's valve system.
Fetal/maternal monitor/monitoring systems serviced or remanufactured using non-OEM equivalent components that have not been appropriately verified or validated. Possible adverse clinical impact: inability to accurately detect and measure fetal heart rate, inability to accurately detect maternal peripheral oxygen saturation, inability to monitor uterine activity to follow contractions, inability to determine temperature, and maternal blood pressure, lack of electrocardiography tracing, patient/clinician burns, and delay in detecting maternal or fetal distress.
Arrow International
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Misprinted IFUs shipped with esophageal stents
The devices may be missing the implant coil.
TELEFLEX MEDICAL
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Arrow International
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Respironics California
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchcreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
TELEFLEX MEDICAL
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
The devices may be missing the implant coil.
Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
Arrow International
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
The devices may be missing the implant coil.
Arrow International
There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
Unknown Manufacturer
The water bottle's clear silicone spout can detach, posing a choking hazard to children.
Fanim Industries, of Zionsville, Ind.
The fan's blade holders can break allowing the blade to be ejected from the fan, posing an injury hazard to consumers.
Textron Specialized Vehicles, of Augusta, Ga
The starter generator wire can be improperly secured, allowing it to come into contact with the vehicle's exhaust, posing a fire hazard.
Unknown Manufacturer
The front wheel hubs on the golf cars can crack causing the front wheels to detach, posing a crash hazard that could result in injury or death to the user or bystander.
Product may be contaminated with Listeria monocytogenes.
Product may be contaminated with Listeria monocytogenes.